isosorbide mononitrate

Product NDC
62175-128
11-digit product format
621750128
Labeler code
62175
Product ID
62175-128_6d91cd6b-f0bf-4e23-97b2-8c659e6f8475
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
isosorbide mononitrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Lannett Company, Inc.
Application
ANDA075155
Marketing category
ANDA
Marketing start
1998-10-30
Marketing end
2024-03-31
Substance
ISOSORBIDE MONONITRATE
Active strength
30 mg/1
Pharmacologic classes
Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
cc3f7505-fd5d-aab9-1128-173349f98a63Product name420230113
f23201a1-1f10-4748-0041-3c03fbb37cfbProduct name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62175-128-37EA - Each62175-128ab6fc793-8689-471a-b44a-2a5e2a2f4ff112012-07-24
62175-128-41EA - Each62175-128a76f62e8-d0b0-4407-a407-48ebc3ace5f012013-02-13
62175-128-43EA - Each62175-1285d8c401e-4145-455f-86e9-20fd2e7ae7d112012-07-24
62175-128-46EA - Each62175-1288483fa60-0a6a-48e0-bbbf-c35cb823983412013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ISOSORBIDE MONONITRATEACTIVE INGREDIENTLX1OH63030ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
ISOSORBIDEACTIVE MOIETYWXR179L51SISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
ISOSORBIDE MONONITRATEACTIVE MOIETYLX1OH63030ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
TALCINACTIVE INGREDIENT7SEV7J4R1UISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
ISOSORBIDE MONONITRATEACTIVE INGREDIENTLX1OH63030ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
ISOSORBIDE MONONITRATEACTIVE INGREDIENTLX1OH63030ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]2
ISOSORBIDE MONONITRATEACTIVE INGREDIENTLX1OH63030ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [UNIT DOSE SERVICES]2
ISOSORBIDEACTIVE MOIETYWXR179L51SISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]2
ISOSORBIDE MONONITRATEACTIVE MOIETYLX1OH63030ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
ISOSORBIDE MONONITRATEACTIVE MOIETYLX1OH63030ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [UNIT DOSE SERVICES]2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317110isosorbide mononitrate 30 MG 24HR Extended Release Oral TabletPSN5a3baddd-1c7f-40a6-b475-ca227a28ef306
31711024 HR isosorbide mononitrate 30 MG Extended Release Oral TabletSCD5a3baddd-1c7f-40a6-b475-ca227a28ef306
317110isosorbide mononitrate 30 MG 24 HR Extended Release Oral TabletSY5a3baddd-1c7f-40a6-b475-ca227a28ef306
317110isosorbide mononitrate 30 MG 24HR Extended Release Oral TabletPSNc550c0a4-3217-40ca-a5f5-51ab27e110055
31711024 HR isosorbide mononitrate 30 MG Extended Release Oral TabletSCDc550c0a4-3217-40ca-a5f5-51ab27e110055
317110isosorbide mononitrate 30 MG 24 HR Extended Release Oral TabletSYc550c0a4-3217-40ca-a5f5-51ab27e110055
311196isosorbide mononitrate 120 MG 24HR Extended Release Oral TabletPSN07c1c818-44ad-44b0-aeec-2bc51193cd523
317110isosorbide mononitrate 30 MG 24HR Extended Release Oral TabletPSN06faac0a-d719-4b54-85df-fdf3a5c6599f3
317110isosorbide mononitrate 30 MG 24HR Extended Release Oral TabletPSN07c1c818-44ad-44b0-aeec-2bc51193cd523
353538isosorbide mononitrate 60 MG 24HR Extended Release Oral TabletPSN07c1c818-44ad-44b0-aeec-2bc51193cd523
31119624 HR isosorbide mononitrate 120 MG Extended Release Oral TabletSCD07c1c818-44ad-44b0-aeec-2bc51193cd523
31711024 HR isosorbide mononitrate 30 MG Extended Release Oral TabletSCD06faac0a-d719-4b54-85df-fdf3a5c6599f3
31711024 HR isosorbide mononitrate 30 MG Extended Release Oral TabletSCD07c1c818-44ad-44b0-aeec-2bc51193cd523
35353824 HR isosorbide mononitrate 60 MG Extended Release Oral TabletSCD07c1c818-44ad-44b0-aeec-2bc51193cd523
311196isosorbide mononitrate 120 MG 24 HR Extended Release Oral TabletSY07c1c818-44ad-44b0-aeec-2bc51193cd523
317110isosorbide mononitrate 30 MG 24 HR Extended Release Oral TabletSY07c1c818-44ad-44b0-aeec-2bc51193cd523
317110isosorbide mononitrate 30 MG 24 HR Extended Release Oral TabletSY06faac0a-d719-4b54-85df-fdf3a5c6599f3
353538isosorbide mononitrate 60 MG 24 HR Extended Release Oral TabletSY07c1c818-44ad-44b0-aeec-2bc51193cd523
317110isosorbide mononitrate 30 MG 24HR Extended Release Oral TabletPSN8c104eaa-d2ec-4403-84a7-8d93b585698e2
31711024 HR isosorbide mononitrate 30 MG Extended Release Oral TabletSCD8c104eaa-d2ec-4403-84a7-8d93b585698e2
317110isosorbide mononitrate 30 MG 24 HR Extended Release Oral TabletSY8c104eaa-d2ec-4403-84a7-8d93b585698e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62175-128-3762175012837100 TABLET, EXTENDED RELEASE in 1 BOTTLE (62175-128-37) 1998-10-302024-03-31NoNoCurrent
62175-128-4162175012841500 TABLET, EXTENDED RELEASE in 1 BOTTLE (62175-128-41) 1998-10-302024-03-31NoNoCurrent
62175-128-43621750128431000 TABLET, EXTENDED RELEASE in 1 BOTTLE (62175-128-43) 1998-10-302024-03-31NoNoCurrent
62175-128-466217501284690 TABLET, EXTENDED RELEASE in 1 BOTTLE (62175-128-46) 1998-10-302024-03-31NoNoCurrent